Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01216280
• Date of registration: 02/09/2010
• Prospective Registration: No
• Primary sponsor: Natrogen Therapeutics International, Inc
• Public title: Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis
• Scientific title: Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis
• Date of first enrolment: July 2010
• Target sample size: 75
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01216280
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Longgui Wang, MD
• Affiliation: Natrogen Therapeutics International, Inc

Key inclusion & exclusion criteria

Inclusion Criteria:

- Females must be of non-childbearing potential evidenced by being surgically sterile,
postmenopausal for at least 12 months or be using acceptable contraception methods.

- Subject is require to meet one of the following criteria:

1. Newly diagnosed patients with moderate to severe ulcerative colitis evidenced by
endoscopy and histopathology, who have never been medically treated for
ulcerative colitis, or

2. Patients with moderate to severe disease, as defined by a Disease Activity Index
(DAI) score of 6-10 (inclusive) at the Baseline Visit (assessed at screening and
verified at Day 1), with a negative evaluation of the terminal ileum within 3
years of the screening visit, or

3. Patients with active ulcerative colitis who are refractory or intolerant to
therapies of 5-ASA, steroids, immunosuppressants or anti-TNF-alpha.

- Endoscopic evidence of active mucosal disease as assessed by flexible sigmoidoscopy,
with a DAI mucosal appearance sub score = 2.

- DAI rectal bleeding sub score of = 1.

- Physician's Global Assessment (PGA) DAI sub score = 2.

- Ability to adhere to the study visit schedule and other protocol requirements.

- Ability to provide voluntary written informed consent.

- Adequate cardiac, renal and hepatic function as determined by site principal
investigator and demonstrated by screening laboratory evaluations, and
questionnaires, and physical examination results that are within normal limits.

Exclusion Criteria:

- History of colonic or rectal surgery.

- Pregnant or breast-feeding.

- Diagnosis of diabetes, heart failure, unstable angina, hepatic cirrhosis, kidney
failure, or any other unstable medical condition.

- Known hypersensitivity to Natura alpha or any of the drug excipients.

- Active and chronic infections.

- Severe ulcerative colitis indicated by Disease Activity Index score > 10.

- Patients with ulcerative proctitis (disease limited to less than 15 cm from the anal
verge).

- Use of any vaccine or any other immunostimulator within 4 weeks prior to the
screening visit. .

- Use of > 2.4 gm mesalamine or equivalent within 2 weeks prior to the screening visit.

- Use of oral corticosteroids for more than 3 days during the two weeks prior to the
screening visit.

- Use of corticosteroid or 5-ASA enemas, foams, or suppositories at any time within two
weeks prior to the screening visit. .

- Use of TNF-alpha antibody or any other biologic therapy within 2 months prior to the
screening visit. .

- Use of immunosuppressive drugs at any time within four weeks prior to the screening
visit. .

- Use of oral or parenteral antibiotics at any time within two weeks prior to the
screening visit.

- Diagnosis of Crohn's disease.

- Diagnosis of indeterminate colitis (inability to distinguish between ulcerative
colitis and Crohn's disease).

- Diagnosis of microscopic colitis (collagenous or lymphocytic colitis).

- Diagnosis of ischemic, infectious (e.g., salmonella, shigella, etc.), or amebic
colitis, or gonococcal proctitis.

- Diagnosis of Clostridium difficile colitis.

- History of positive serology to hepatitis B or C or human immunodeficiency virus
(HIV) infection.

- Active alcohol or drug abuse.

- Known malignancy or history of malignancy that would reduce life expectancy.

- Current smoker, or has been a smoker within 6 months prior to the screening visit.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: placebo capsule

Drug: 10 mg Natura-alpha capsule and 10 mg placebo capsule

Drug: 2 x 10 mg Natura-alpha capsules

Primary Outcome(s)

Physician's Global Assessment(PGA) [Time Frame: Day 28 after the treatment]

Secondary Outcome(s)

Physician's Global Assessment (PGA) [Time Frame: Day 28 after the treatment]

Physician's Global Assessment (PGA) [Time Frame: 14]

Physician's Global Assessment (PGA) [Time Frame: Day 28]

Physician's Global Assessment (PGA) [Time Frame: Day 7]

Safety [Time Frame: Day 28]

Secondary ID(s)

70984

NTI-2009-UC1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors